MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH TSL - PERMACOL¿; MESH, SURGICAL

Model Number P101520

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Hernia (2240); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hernia.It was reported that after implant, the patient experienced recurrence, mesh migration, pain and infection.Post-operative patient treatment included excision surgery.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of recurrent bilateral inguinal hernias.It was reported that after implant, the patient experienced recurrence, mesh migration, pain and infection.Post -operative patient treatment included excision surgery.The product had been used with 0112970 bard mesh perfix plug (right), lot# huyg0854 and 0112970 bard mesh perfix plug (left), lot# huwl1317.

Manufacturer Narrative

Concomitant medical products: 0112970 bard mesh perfix plug (right) (lot# huyg0854) , 0112970 bard mesh perfix plug (left) (lot# huwl1317).If information is provided in the future, a supplemental report will be issued.

• Brand Name: MESH TSL - PERMACOL¿
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire CT GU11 1EJ; GB GU11 1EJ
• MDR Report Key: 8881874
• MDR Text Key: 153941354
• Report Number: 1219930-2019-04681
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 10884523000122
• UDI-Public: 10884523000122
• Combination Product (y/n): N
• PMA/PMN Number: 2019-07-24
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2016
• Device Model Number: P101520
• Device Catalogue Number: P101520
• Device Lot Number: 13B1309X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR